NCT07283913 Non-invasive Ultrasonic Auricular Vagus Nerve Stimulation
| NCT ID | NCT07283913 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nottingham |
| Condition | Healthy Participants |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-10-01 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The Vagus nerve, one of 12 cranial nerves that connect the brain to the human body, controls specific involuntary functions such as breathing, heart rate, the digestive system and the immune system, and it is crucial to unlocking the relaxation response (parasympathetic nervous system). Vagus nerve stimulation (VNS) can be invasive or non-invasive, and both methods have been trialled in research studies. Some non-invasive VNS involves the use of a device which is placed on the skin, to send electrical impulses to the Vagus nerve. The device sends electrical impulses to some areas of the brain which changes brain activity and helps in treating certain disorders. Invasive methods utilise a surgically implanted Vagus nerve stimulator on the left Vagus nerve in the neck area. VNS is used in treatment of epilepsy and studies has shown to have a therapeutic effect on treatment resistant depression. Currently, research indicates that invasive VNS to treat anxiety yield mixed results, whilst other studies suggest that VNS with exposure-based therapies might enhance outcomes for anxiety patients. Stimulating the Vagus nerve comes with serious technical challenges. Most importantly, electric currents follow the path of least resistance. When running through biological tissues, such as skin, cartilage or bone, it is difficult to aim for the part of the body that needs to be stimulated. This means it isn't always easy to tell whether the Vagus nerve is indeed being stimulated and how much of the current is reaching the Vagus nerve. This problem can be overcome by ultrasound stimulation. Ultrasound stimulation employs high frequency sound waves to stimulate tissue. These soundwaves travel through the human body much more predictably than electric currents. As such, ultrasound stimulation of the Vagus nerve may be more effective than electrical stimulation. The ZenBud device is designed to apply ultrasound stimulation to part of the auricular branch of the Vagus nerve. Ultrasound stimulation allows for more targeted stimulation, increasing the chance of the stimulation reaching the Vagus nerve. The ZenBud device is safe for use in healthy adults and received CE marking. Before testing the therapeutic effect of the Zenbud on patients with symptoms it is important to identify physiological, cognition or emotional changes in health volunteers. Identifying these changes could lead to identifying possible future therapeutic uses for ultrasound-VNS (U-VNS).
Eligibility Criteria
Inclusion Criteria * Participant is willing and able to give informed consent for participation in the study * Not currently taking any medications (except the contraceptive pill) * Aged 18 or over * Good general health * Able and willing to remove any piercings in the left ear * Able to abstain from exercise and fast from food for 12 hours before the second and third visit Exclusion Criteria * Current or past diagnosis of a major neurological, neurosurgical, or psychiatric disorder (including self-reported depression) * Inability to complete informed consent process * Personal history of cardiac arrhythmia * Diabetes * High blood pressure (\>140 mmHg systolic and/or \>90 mmHg diastolic) * Other significant medical condition (including cardiological disorders; specific details to be reviewed by the CI prior to inclusion) * Use of medication or recreational drugs that affect the nervous system in the past 3 months * Medication intake (such as beta-blockers, glucocorticoids, antidepressants, anti-inflammatory drugs) in the last 7 days - contraceptive medication in women is allowed * Currently pregnant or breastfeeding * Allergy to aquasonic gel or any of its components (propylene glycol, glycerin, isothiazolinones) * Participation in a research study in the last 3 months involving invasive procedures or an inconvenience allowance (required for all UoN FMHS UREC-approved studies) * BMI \< 18 kg/m² or \> 30 kg/m² * Excessive consumption of alcohol (\>2 alcoholic beverages/day) or tobacco (\>5 cigarettes/day) * Previous experience with stress tests * Known infection in the last 8 weeks
Contact & Investigator
Marcus Kaiser, Professor
PRINCIPAL INVESTIGATOR
University of Nottingham
Frequently Asked Questions
Who can join the NCT07283913 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Healthy Participants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07283913 currently recruiting?
Yes, NCT07283913 is actively recruiting participants. Contact the research team at Alicia.falconcaro@nottingham.ac.uk for enrollment information.
Where is the NCT07283913 trial being conducted?
This trial is being conducted at Nottingham, United Kingdom, Nottingham, United Kingdom.
Who is sponsoring the NCT07283913 clinical trial?
NCT07283913 is sponsored by University of Nottingham. The principal investigator is Marcus Kaiser, Professor at University of Nottingham. The trial plans to enroll 30 participants.